- Catalent (Manassas, VA)
- …cross-functional areas in regulatory requirements. The Associate Director, Regulatory Affairs will review change control for potential impact on client ... Associate Director, Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry… more
- Aequor (Seattle, WA)
- …Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document ... inputting and expressing Quality principles Position Reports to Jenna Walker - Associate Director, QA Training & Document Control Education: Bachelor's degree… more
- Merck & Co. (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine.The Associate Specialist participates in a team of analysts in the development, ... process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of product samples… more
- Merck & Co. (Rahway, NJ)
- …management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …discharge compliance. Develops and improves site policies, prepares and submits regulatory reports, independently track recurring regulatory reports & permitting ... referral: 0 Essential Functions Environmental & Waste Management Prepare and submit regulatory reports and filings, to include: air emissions, Tier II, Toxics… more
- Merck & Co. (Rahway, NJ)
- …appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study ... issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.Identifies, assesses… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... who interact with PMRT in accordance with the AOP; maintain training documentsQuality Control of all PMRP Material Access review material through the PMVP Confirm… more
- Merck & Co. (Rahway, NJ)
- …maintaining detailed Project Plans, Risk Plans, Issue Logs, and other control artifacts.Serve as a key communication conduit, coordinating closely with Subject ... of the pharmaceutical/Life Sciences industry, including an understanding of regulatory requirements and industry trendsExperience as a consultant, preferably with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Position This position is responsible for coordinating/supporting/assisting the Quality Control team including offsite and onsite calibrations, quality system ... with various departments Working in gLIMS Data entry into Regulatory Asset Management System (RAM) Work with supervisor on...minimum of three (3) years relevant experience, or an Associate 's degree or equivalent with one (1) or more… more
- Aequor (Thousand Oaks, CA)
- …determined by the Variation Lead for reportable changes for Global Distribution control . May also translate product launch/variation strategy as determined by the ... to an executable implementation plan for launch/variation changes for Customer Facing SKU control . This role will own the execution of the implementation plan in… more
- American Honda Motor Co Inc (Marysville, OH)
- …professional experienceDetailed knowledge in the following areas is necessary: internal control , risk assessment and mitigation, legal / regulatory ... AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest quality and… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Catalent (Harman, WV)
- …limited to, purchasing, sourcing, logistics, warehousing, inventory management and control , material forecasting, functional capacity planning and sourcing, S&OP ... recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to procurement.Develop and continuously… more
- Merck & Co. (Durham, NC)
- …and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key automation-related ... processesProviding direct support for regulatory inspections and audits and other validation activities by...Technical organizations to resolve complex problems. Responsible for Fermentation control Systems specific to areas of Seed and Production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Computerized maintenance management systems (CMMS). Quality Management knowledge, including Change control , Deviation, and CAPA's. EHS and regulatory standards ... and documented in accordance with all cGMP, company policies, and appropriate regulatory standards. Performs work review, approval and close out of work orders,… more
- Software Galaxy Systems, LLC (Plaquemine, LA)
- …processes, quality checks, testing, sampling, and sanitation activities. Audit quality control of raw materials, packaging components, labels, and finished products ... to ensure compliance with established specifications and regulatory standards. Review, revise, and create SOPs as needed. Assist in the implementation of policies,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role is eligible for relocation assistance. Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: none, this is ... ongoing supervision and development opportunities Support the submission of worldwide regulatory filings Performs all job duties and responsibilities in a compliant… more
